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NCT01766128: ZONIST
Randomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson Disease
Phase 2/Phase 3 trial testing Zonisamide in Parkinson Disease. Withdrawn.
1 February 2013
Quick facts
| Lead sponsor | Mazandaran University of Medical Sciences |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 1 February 2013 |
| Primary completion | 1 February 2013 |
| Estimated completion | 1 February 2013 |
Drugs / interventions tested
- Zonisamide — full drug profile →
- Placebo
Conditions studied
- Parkinson Disease — all drugs for Parkinson Disease →
Sponsor
Mazandaran University of Medical Sciences
Who can join
Adults 45 to 85, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time to need for dopaminergic therapy
Time frame: Baseline and month 6
Sponsor's own description
The aim of this study is investigation of neuroprotective effect of zonisamide in early Parkinson disease. A total of 60 patients with early Parkinson disease who meet the study criteria will be enrolled and randomized into two groups alternately based on their visit date. Demographic data, Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn\&Yahr and modified Schwab\&England activities of daily living scale will be determined and registered for each patient. Patients of group A will be treated by zonisamide 50mg/d for 12 months and the other group will be treated by placebo for the same time. Primary endpoint is occurrence of parkinsonian symptoms which interfere with patients' daily activity or cause psychosocial embarrassment. The mentioned scores will be registered every 2 months for both groups by blinded neurologist and also regular blood test will be performed to prevent drug adverse events.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Pathogenesis-targeted, disease-modifying therapies in Parkinson disease.
AlDakheel A, Kalia LV, Lang AE. · · 2014 · cited 93× · PMID 24085420 · DOI 10.1007/s13311-013-0218-1 -
Systemic QSAR and phenotypic virtual screening: chasing butterflies in drug discovery.
Cruz-Monteagudo M, Schürer S, Tejera E, Pérez-Castillo Y, et al · · 2017 · cited 21× · PMID 28274840 · DOI 10.1016/j.drudis.2017.02.004 -
Zonisamide: a review of the clinical and experimental evidence for its use in Parkinson's disease.
Grover ND, Limaye RP, Gokhale DV, Patil TR. · · 2013 · cited 13× · PMID 24347760 · DOI 10.4103/0253-7613.121266
Verify or expand the search:
- PubMed search for NCT01766128
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Zonisamide
Trials testing the same drug.
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- NCT05205811 — The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette · Phase 3 · completed
- NCT04388319 — Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes · Phase 3 · completed
- NCT03376139 — Zonisamide Outpatient Study · Phase 2 · withdrawn
- NCT02049073 — Prevention of Noise-induced Hearing Loss · Phase 1, PHASE2 · withdrawn
Other recruiting trials for Parkinson Disease
Currently open trials in the same condition.
- NCT07399496 — Accelerated TMS for Apathy in PD · NA · recruiting
- NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
- NCT07442370 — The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients · NA · recruiting
- NCT06848205 — Percept Transitions in FOG and PD · NA · recruiting
- NCT07432958 — A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (P · Phase 2 · recruiting
Other Mazandaran University of Medical Sciences trials
Trials by the same sponsor.
- NCT06737406 — Topical 5-Fluorouracil (5FU) Plus Calcipotriol in Children With Palmoplantar Wart · NA · recruiting
- NCT06812000 — Post-stroke Seizure and Epilepsy Following Thrombolytic Therapy · completed
- NCT06653348 — Ticagrelor Based De-Escalation of Dual Antiplatelet Therapy in Ischemic Stroke · Phase 2, PHASE3 · recruiting
- NCT07120841 — Nurse Telephone Follow-up for Cardiovascular Patients · NA · completed
- NCT07210450 — Effect of L-Glutamine on Pulmonary Artery Pressure in Patients With Non-Transfusion-Dependent Thalassemia · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01766128 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mazandaran University of Medical Sciences
- Last refreshed: 8 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01766128.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing