Multicenter, randomized, double-blind, parallel-group clinical trial to evaluate the efficacy and safety of Safinamide versus Rasagiline in fatigue associated with Parkinson's Disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

13 Dec 2023 → ongoing

Decision date (initial)

2023-09-07

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: Therapy, Dose response

Evaluate the safety of Safinamide and Rasagiline administered for 6 months by measuring blood pressure (BP), heart rate (HR), blood tests, Movement Disorders Society Unified Parkinson's Disease Rating Scale part III (MDS UPDRS-III), ECG, and recording adverse effects.

Secondary objectives 1

1. Evaluate if Safinamide and Rasagiline, administered for 6 months as adjunctive therapy to stable doses of levodopa (alone or in combination with other antiparkinsonian drugs), will lead to a reduction in fatigue measured by the Fatigue Severity Scale , from baseline to 6 months.

Conditions and MedDRA coding

Fatigue symptoms associated with Parkinson´s Disease.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Subjects of both sexes aged between 50-80 years.
2. Diagnosis of Parkinson´s Disease based on MDS criteria (Postuma, 2015) (45) with at least three years of Parkinson´s Disease duration, based on medical history and neurological examination.
3. Neuroimaging compatible with Parkinson´s Disease.
4. Hoehn and Yahr (H&Y) stage I-IV (included) during the 'ON' phase (Hohen, 1967).
5. Presence of fatigue since at least one month prior to the initial visit defined by a mean Parkinson's Fatigue Scale (PFS) fatigue score ≥ 8 ((Brown et al. 2005; Stocchi et al. 2014; Niimi et al. 2019).
6. Treatment with levodopa (alone or with other antiparkinsonian medications) at a stable dose for at least 4 weeks prior to the screening visit.
7. Subjects who can give written consent to participate in the study.

Exclusion criteria 13

1. A score of less than 23 on the MoCA global cognitive rating scale (Dalrymple-Alford, 1995).
2. Severe motor complications (moderate-severe motor fluctuations defined as a score >1 on MDS UPDRS Part IV item 42; or disabling dyskinesias defined as a score >1 on MDS UPDRS Part IV item 36).
3. History of Deep Brain Stimulation.
4. Pregnancy, gestational desires, refusal to use adequate contraception, or breastfeeding.
5. Insufficient level of Spanish or local language, illiteracy, sensory disturbances (vision, hearing), legal disability or any other mental, physical or social situation that prevents giving the informed consent form or adequately completing the evaluations.
6. History or impression, at the investigator's discretion, of low therapeutic compliance.
7. Active major psychiatric illness or with antipsychotic treatment: major hallucinations, with a score ≥3 on item 2 (thought disorder) of the MDS-UPDRS Section 1, severe Impulse Control disorder, major depression according to DSM (Diagnostic and Statistical Manual) and score ≥3 on item 3 of the MDS-UPDRS Section 1.
8. Patients with diagnostic criteria for Apathy with a score ≥3 on item 4 of the MDS-UPDRS Section 1.
9. Current diagnosis of substance abuse or history of alcohol or drug abuse in the 3 months prior to the initial visit.
10. Current clinically significant or unstable medical illness (gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiovascular, neoplastic, sleep disorders) that would preclude study participation or contribute to fatigue (such as anemia, active neoplasm, or hypothyroidism), as judged by the clinical judgment of the investigator.
11. Treatment with Selegiline, Rasagiline, Safinamide (or any other MAO-B inhibitor) for at least 2 months prior to study inclusion.
12. Hypersensitivity or intolerance to Rasagiline, Safinamide or any of their excipients.
13. Any significant alteration in the anamnesis, examination, vital signs or laboratory tests that, in the investigator's opinion, contraindicate participation in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Changes in the Fatigue Severity Scale (FSS) score.

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Sponsor organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Address

Calle De San Quintin 77-79

City

Barcelona

Postcode

08041

Country

Spain

Scientific contact point

Organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Contact name

UICEC

Public contact point

Organisation

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Contact name

UICEC

Locations

1 EU/EEA country · 11 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 15 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