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Longer-term safinamide treatment early in Parkinson's

Researchers are comparing doses and placebo alongside another Parkinson's medicine to study effects and safety over time.

Testing a treatment or activity · Study reference: CTRI-2009-091-000987

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Looking for volunteers

Start (reported date)
2009-09-28

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age range not listed · Ask the team who can join

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: Not reported

Inclusion criteria: Inclusion Criteria: To be eligible for inclusion into this trial, the subjects must fulfill all of the following criteria: 1. The subject completed 24 weeks of Trial 27918. 2. The subject successfully completed all trial requirements in Trial 27918. 3. If female, they must be either post-menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as: ?All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive?. 4. Subject is willing and able to participate in the trial and has provided written, informed consent Exclusion criteria: 1. If female, the subject is pregnant or lactating. 2. The subject experienced a clinically significant adverse effect during Trial 27918 that could put the subject at risk according to the investigator?s opinion. 3. The subject has shown clinically significant deterioration during participation in Trial 27918. 4. Motor deterioration during trial 27918 that required upward titration of existing antiparkinsonian medication or the initiation of an additional anti-parkinsonian medication. 5. The investigator deems it is not in the subject?s best interest to participate to trial 27938. 6. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Full study name & original research details

Official study title

A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson's disease treated with a stable dose of a single dopamine agonist.

Original description

Intervention: Intervention1: Safinamide: Safinamide 50 mg at Weeks 12, 24, 36, 48, 60 and 78 Control Intervention1: Safinamide: safinamide 100 mg Weeks 12, 24, 36, 48, 60 and 78 Control Intervention2: Placebo: Weeks 12, 24, 36, 48, 60 and 78 Primary outcome: Change in the dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacyTimepoint: Time from baseline to first intervention Secondary outcome: Proportion of subjects requiring intervention ? UPDRS Section III (motor) score change from baseline to W78 ? UPDRS Section II (ADL) score change from baseline to W78 ? CGI ? Change scale score, change from Day 0 of Trial 27918 to W78 ? CGI ? Severity scale score change from baseline to W78EQ-5D score change from baseline to W78 ? PDQ-39 score change from baseline to W78 ? Cogtest® PD battery test score change from baseline to W78 Timepoint: From baseline to Week 78

Conditions reported: Not reported

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Intervention1: Safinamide: Safinamide 50 mg at Weeks 12, 24, 36, 48, 60 and 78 Control Intervention1: Safinamide: safinamide 100 mg Weeks 12, 24, 36, 48, 60 and 78 Control Intervention2: Placebo: Weeks 12, 24, 36, 48, 60 and 78
Phases
Phase 3
Sponsor
In USA :EMD Serono, Inc One Technology Place, Rockland MA 02370Other countries: Merck Serono S.A. - Geneva 9 Chemin des Mines1202 Geneva Switzerland
Start date reported by registry
2009-09-28 (reported)

Registry updated: Not reported · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-14 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Dr. Khokan Debnath · +91-22-66609070 · amarinder.singh@merck.co.in

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Facility not reported

India

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.