L-DOPA-Induced DyskinesiaNCT04173832
Clinical Study on Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
A study testing Tianqi Pingchan Granule Combined With Amantadine in people with L-DOPA-Induced Dyskinesia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- L-DOPA-Induced Dyskinesia
- What is being tested?
- Tianqi Pingchan Granule Combined With Amantadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD patients between the ages of 30-85;
- Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points;
- The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour;
- The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment;
- Levodopa is administered at least three times a day.
Who cannot join
- PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia;
- pregnant and lactating women;
- Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment;
- Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points;
- Psychiatric symptoms associated with anti-Parkinson's disease drugs
- accompanied by a history of mental illness;
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- impaired liver and kidney function;
- accompanied by severe other systemic diseases;
- Amantadine treatment has been received within the first 30 days of enrollment;
- History of medication with apomorphine or dopamine receptor antagonists;
- Previously taking amantadine, unable to tolerate;
- Allergic to the amantadine, memantine, and traditional Chinese medicine preparations or serious adverse reactions;
- Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
- has received PD-related brain surgery;
- Patients who are participating in other clinical studies or have participated in other clinical studies within the previous 30 days;
- Patients who are unable to follow up with follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Yu Zhang, Doctor, 8613916006909, zhangyu0330@126.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.
- Conditions
- L-DOPA-Induced Dyskinesia
- Being tested
- Tianqi Pingchan Granule Combined With Amantadine, Placebo Combined With Amantadine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tianqi Pingchan Granule Combined With AmantadineDrug
Tianqi Pingchan Granule and Amantadine are given to patients simultaneously
Placebo Combined With AmantadineDrug
Placebo and Amantadine are given to patients simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Tianqi Pingchan Granule Combined With Amantadine | Experimental | Not described Receives: Drug: Tianqi Pingchan Granule Combined With Amantadine |
| placebo Combined With Amantadine | Placebo comparator | Not described Receives: Drug: Placebo Combined With Amantadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Dyskinesia Rating Scale (UDysRS)
The change from baseline to day 84 of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
Measured: up to 12 weeks
Secondary outcomes (3)
Patient diaries
Change in daily "OFF"-time as assessed with patient diaries from run-in to day 84. This is a self administered diary where patients assess their motor state every half hour during 24 hours.
Measured: up to 12 weeks
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Baseline (Day 1) to day 84. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.
Measured: up to 12 weeks
Clinical Global Impression
Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with "no change
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for L-DOPA-Induced DyskinesiaStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Longhua Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Wenzhou Central Hospital, The Affiliated Hospital of Qingdao University, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173832
- Sponsor's protocol ID
- XHEC-C-2019-032-2
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2019
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Zhu XB, Zhao Y, Cui GY, Li WT, Yuan CX, Huang JP, Wan Y, Wu N, Song L, Zhao JH, Liang Y, Xu CY, Liu MJ, Gao C, Chen XX, Liu ZG. Efficacy and safety of Tianqi Pingchan Granule, a compound Chinese herbal medicine, for levodopa-induced dyskinesia in Parkinson's disease: A randomized double-blind placebo-controlled trial. J Integr Med. 2024 Sep;22(5):545-551. doi: 10.1016/j.joim.2024.07.002. Epub 2024 Jul 9.
PubMed 39060125
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study of Treatment of L-DOPA-Induced Dyskinesia With Tianqi Pingchan Granule Combined With Amantadine
- ClinicalTrials.gov ID
- NCT04173832
- Acronym / sponsor ID
- XHEC-C-2019-032-2
- Conditions
- L-DOPA-Induced Dyskinesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Longhua Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Wenzhou Central Hospital, The Affiliated Hospital of Qingdao University, Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine, The Affiliated Hospital of Xuzhou Medical University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, placebo-controlled, multi-center clinical trial was conducted to observe the improvement in the level of dyskinesia in patients with Parkinson's disease during the 12-week period of oral treatment with Tianqi Pingchan Granule Combined With Amantadine. To observe the differences of the safety and effectiveness between Tianqi Pingchan Granule combined with amantadine and placebo combined with amantadine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tianqi Pingchan Granule Combined With Amantadine | Experimental | Drug: Tianqi Pingchan Granule Combined With Amantadine |
| placebo Combined With Amantadine | Placebo comparator | Drug: Placebo Combined With Amantadine |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PD patients between the ages of 30-85;
- Patients with Parkinson's disease dyskinesia, and UPDRS 4.2 score ≥ 2 points;
- The patient diary shows that there are at least two opening periods between 9 am and 4 pm every day, and the dyskinesia appears in the opening period, each time lasting more than half an hour;
- The treatment plan for anti-Parkinson's disease is stable and not adjusted within 30 days before enrollment;
- Levodopa is administered at least three times a day.
Key exclusion criteria (16 listed)
- PD patients with biphasic, dystonia, closure, myoclonus, but no dyskinesia;
- pregnant and lactating women;
- Taking other Chinese medicines against Parkinson's disease 2 weeks before enrollment;
- Impaired cognitive function (according to pre-entry MMSE score): secondary education level: MMSE <24 points; primary education level <20 points; illiterate <17 points;
- Psychiatric symptoms associated with anti-Parkinson's disease drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tianqi Pingchan Granule Combined With AmantadineTianqi Pingchan Granule and Amantadine are given to patients simultaneously | Drug | Tianqi Pingchan Granule Combined With Amantadine |
| Placebo Combined With AmantadinePlacebo and Amantadine are given to patients simultaneously | Drug | placebo Combined With Amantadine |
Primary outcome
Unified Dyskinesia Rating Scale (UDysRS)
Time frame: up to 12 weeks
The change from baseline to day 84 of treatment in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
3 secondary outcomes
Patient diaries
Time frame: up to 12 weeks
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: up to 12 weeks
Clinical Global Impression
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Derived from this study: PubMed 39060125Zhang Y, Zhu XB, Zhao Y, Cui GY, Li WT, Yuan CX, Huang JP, Wan Y, Wu N, Song L, Zhao JH, Liang Y, Xu CY, Liu MJ, Gao C, Chen XX, Liu ZG. Efficacy and safety of Tianqi Pingchan Granule, a compound Chinese herbal medicine, for levodopa-induced dyskinesia in Parkinson's disease: A randomized double-blind placebo-controlled trial. J Integr Med. 2024 Sep;22(5):545-551. doi: 10.1016/j.joim.2024.07.002. Epub 2024 Jul 9.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tianqi Pingchan Granule Combined With Amantadine in people with L-DOPA-Induced Dyskinesia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, MD (13916006909, zhangyu0330@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Dyskinesia Rating Scale (UDysRS) (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.