A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cerevel Therapeutics LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

27 May 2021 → 2 Dec 2025

Decision date (initial)

2024-06-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Cerevel Therapeutics, LLC

External identifiers

EU CT number

2024-512123-37-00

EudraCT number

2019-002952-17

ClinicalTrials.gov

NCT04760769

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To evaluate the safety and tolerability of long-term administration of tavapadon in subjects with PD.

Secondary objectives 3

1. To evaluate the effects of tavapadon on PD symptoms during long-term treatment.
2. To evaluate the effects of tavapadon on L-Dopa usage
3. To evaluate speech and facial expression characteristics of subjects with PD (US sites only)

Conditions and MedDRA coding

Parkinson's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Subjects who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 or Trial CVL-751-PD-003 or the 27-week doubleblind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover subjects from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
2. 2. Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
3. 3. Subjects who are capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
4. 4. Subjects who are able, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
5. 5. Subjects who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial.
6. 6. Subjects who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.

Exclusion criteria 6

1. Rollover Subjects: 1. Subjects who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial.
2. 2. Subjects who, in the judgement of the investigator, experienced poor tolerability to the IMP during the double-blind trial or whose safety assessments resulted in new concerns that would suggest that the subject may not be appropriate for a 58-week trial of tavapadon.
3. 3. Subjects who, in the judgment of the investigator, were noncompliant with trial procedures or with IMP administration during the double-blind trial.
4. 4. Subjects who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Subjects who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 CSSRS Suicidal Behavior Items occurred within the last 2 years, OR Subjects who, in the opinion of the investigator, present a serious risk of suicide.
5. 5. Subjects who, in the judgment of the investigator, had a clinically significant medical, surgical, psychiatric, or laboratory abnormality after completing the last trial visit in the double-blind trial that would compromise participation in this trial.'
6. 6. Subjects who had previously been enrolled in this open-label trial and had subsequently withdrawn.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To Evaluate the safety and tolerability of long-term administration of tavapadon in subjects with PD: •Nature, frequency, and temporality of TEAEs (nonserious and serious), including abuse related AEs and AEs related to MHIs •Frequency of discontinuations •QUIP RS •ESS •C-SSRS •SMWQ •Clinical laboratory evaluations •Vital signs •Physical and neurological examinations •ECGs

Secondary endpoints 3

1. To Evaluate the effects of tavapadon on PD symptoms during long-term treatment • Change from baseline in the MDS-UPDRS Parts I, II, and III scores • Change from baseline in the Hauser diary (only in subjects who require daily L-Dopa or equivalent therapy for symptom control at the time of enrollment) • Change from baseline in the EQ-5D-5L index and VAS scores
2. To evaluate the effects of tavapadon on L-Dopa usage: •Change from baseline in L-Dopa usage
3. To Evaluate speech and facial expression characteristics of subjects with PD: •Exploratory analyses of audio and video data collected from subject administered remote digital testing of speech and facial expressions through an interactive application platform on the subject's personal mobile device may be conducted

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cerevel Therapeutics LLC

Sponsor organisation

Cerevel Therapeutics LLC

Address

222 Jacobs Street Suite 200

City

Cambridge

Postcode

02141-2297

Country

United States

Scientific contact point

Organisation

Cerevel Therapeutics LLC

Contact name

Stephanie Pfister

Public contact point

Organisation

Cerevel Therapeutics LLC

Contact name

Cerevel Clinical Trials

Third parties 4

Locations

8 EU/EEA countries · 60 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 162 files

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

Application history

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