Efficacy and Safety of Cromoglycate as a New Symptomatic Treatment in Patients with Multiple Sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

1 Oct 2024 → ongoing

Decision date (initial)

2023-12-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

To evaluate the efficacy on fatigue of treatment with oral disodium cromoglycate (200-400 mg) versus placebo in patients with mutiple sclerosis.

Secondary objectives 3

1. To evaluate the efficacy on urinary dysfunction of treatment with oral disodium cromoglycate (200-400 mg) versus placebo in urinary incontinence in patients with multiple sclerosis.
2. To evaluate the effect of treatment with oral disodium cromoglycate (200-400 mg) versus placebo on urinary incontinence, quality of life, emotional state, bowel function, sexual function, labor productivity, disease progression, and functional magnetic resonance imaging in patients with multiple sclerosis
3. To evaluate the safety of treatment with oral disodium cromoglycate in patients with multiple sclerosis.

Conditions and MedDRA coding

Multiple sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age between 18 and 65 years.
2. Diagnosis of multiple sclerosis according to the 2017 McDonald criteria, with more than 6 months of follow-up and clinically stable (without flare-ups or new lesions) in the last 6 months.
3. EDSS between 1.0 and 6.5 points.
4. Presence of moderate fatigue for at least 6 months (defined by a score on the MFIS scale ≥ 33 points) and urinary dysfunction (defined by 2 points or more on the ABSST Test).

Exclusion criteria 10

1. Inability to understand or sign the informed consent.
2. Concomitant pathologies of the CNS or diseases that, in the opinion of the investigator, may alter the control of micturition.
3. Patients with permanent urinary catheters.
4. Severe renal or hepatic impairment, history of myocardial infarction, or other clinically significant medical problems that, in the opinion of the investigators, may expose the patient to undue risk or harm, or render the patient unable to complete the study.
5. Abnormal results on baseline blood tests, defined as: serum alanine transaminase or aspartate transaminase levels greater than five times the upper limit of normal, serum creatinine level greater than 1.5 mg/dL, or estimated glomerular filtration rate less than 60 mL /min/1.73 m2.
6. Change in disease-modifying therapy in the last 3 months.
7. Change in symptomatic treatment of fatigue and/or urinary incontinence in the last 3 months.
8. Pregnant or lactating women.
9. Inability to perform MRI (claustrophobia, pacemakers, metal implants) or known allergy to gadolinium.
10. Hypersensitivity to sodium cromoglycate or to any of the excipients (microcrytalline cellulose).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Modified Fatigue Impact Scale (MFIS) at the end-of-treatment visit (V4) with respect to baseline.
2. Fatigue Severity Scale (FSS).
3. Patient-reported outcome measurement information system for fatigue in multiple sclerosis (PROMIS-SF-Fatigue).

Secondary endpoints 39

1. Actionable Bladder Symptom Screening Tool (ABSST).
2. Urinary incontinence questionnaire (ICIQ-SF).
3. Sandvik incontinence severity test.
4. Bladder Control Scale (BLCS).
5. International Prostate Symptom Scale (IPSS).
6. Questionnaire on the specific impact of urinary problems on quality of life (Qualiveen)
7. SF-36 quality of life questionnaires.
8. EQ-5D quality of life questionnaire.
9. Hospital Anxiety and Depression Scale (HADS).
10. Beck Depression Inventory (BDI).
11. Expanded Disability Status Scale (EDSS).
12. Test of the 25 steps.
13. Test of the 9 sticks.
14. Time of multiple sclerosis progression.
15. New lesions evaluated by magnetic resonance imaging
16. Presence of global cerebral atrophy, thalamic atrophy and cortical atrophy, and correlation with changes in fatigue.
17. Presence of mutation 816V c-kit gene, cytokine levels and activation of lymphocyte populations and correlation with changes in fatigue.
18. Axonal damage and macular volume assessed by optical coherence tomography.
19. Modified ASHWORTH scale.
20. Bowel Control Scale (BWCS).
21. Questionnaire on intimacy and sexuality in MS (MSISQ-19).
22. Work Productivity and Activity Impairment Scale (WPAI).
23. Patient symptom scales.
24. Symbols and Digits Test (SDMT).
25. Perineal and perianal sensitivity.
26. Bulbocavernosus reflex.
27. Anal sphincter tone.
28. In women: presence of prolapses.
29. Postvoid residue.
30. Peak flow in uroflowmetry.
31. Detrusor contractions in cistonanometry.
32. Urination difficulty assessed by flow pressure test (maximum flow).
33. PAD test value in 24 hours.
34. Voiding diary: Urinated volume, urgency, urine leakage, urge incontinence, stress incontinence, moulting, and drinking.
35. Treatment-related adverse events
36. Analytical values ​​of complete blood count, biochemistry, hepatorenal and thyroid profile, serum tryptase, urine strip, systematic and urine sediment and pregnancy test.
37. Concomitant medication.
38. Modifying treatment.
39. Modified fatigue impact scale (MFIS) at each treatment visit with respect to baseline.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

Sponsor organisation

Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

Address

Calle Del Profesor Martin Lagos

City

Madrid

Postcode

28040

Country

Spain

Scientific contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

Contact name

Celia Oreja-Guevara

Public contact point

Organisation

Fundacion Para La Investigacion Biomedica Del Hospital Clinico San Carlos

Contact name

Unidad de Investigación Clínica y Ensayos Clínicos

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications