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Indian clinical trial data for drugs like safinamide and apomorphine pump therapy are key for global pharma to seek US FDA approval. This along with specific therapies like gene based treatments targeting specific molecules in the cells are being experimented to give better relief to the Parkinson’s disease (PD) patients.
The country accounts for a large patient pool of elderly and under 40 years patients diagnosed of Parkinson’s disease. The access to English speaking patient pool, panel of neurology specialists along with the required infrastructure support systems are the key factors making international pharma consider India for human studies.
There are various clinical and basic science trials going on in India. Some of them are pan-India multi-centric studies involving various major neurological centers/movement disorders from India. Genetics of Pan-India: Young onset Parkinson's disease (GOPI-YOPD) is one such study being done by a collaborative group of movement disorders specialists in India along with Medgenome to understand the genetic cause of Parkinson's disease in young patients.
Another international study by the Michael J Fox Foundation working on Parkinson's disease research involves understanding the genetic pattern of the condition. This trial is in the process of recruiting 10,000 subjects from India.
Understanding of Parkinson's disease has been increasing over time. Latest two new drugs in India are the apomorphine pump therapies and safinamide. The FDA approval of safinamide was based upon majority of data being from India, Dr Prashanth LK, consultant neurologist and Parkinson’s disease & movement disorder specialist, Vikram Hospital, Bengaluru told Pharmabiz.
This is important because most global studies currently relate to only Europeans and Americans. Vikram Hospital is one of the leaders in the multicentric pan-Indian Parkinson’s disease research along with AIIMS, NIMHANS, Centre for Brain Research, IISc, Centre for cellular and Molecular biology. Vikram Hospital has been one of pioneer hospitals in India for initiation of apomorphine pump therapies, he added.
On the occasion of the Parkinson's Disease Day, observed on April 11, with the theme for this year being will be mental health in Parkinson’s, medical experts experienced the challenge treating the patients who experienced emotionally disturbed spells.
The Covid-19 pandemic outbreak and the ensuing lockdowns were a major blow to clinical trials globally This saw many new research and clinical trial projects to be shelved. Specifically human studies for Parkinson's disease where in regular follow up and assessment were required to be done were impacted.
Further the coronavirus disease also affected the elderly population adversely. Patients with Parkinson's disease were low on immunity and contracted Covid-19. It affected these patients at various levels with emotional disturbances, worsening of Parkinsonism symptoms and de-novo cases too who manifested PD symptoms for the first time when diagnosed of Covid infections. It was here the Indian embassies helped in procuring medications and apomorphine injections with prescriptions from the treating doctors, said Dr. Prashanth.
Dr Kiran S Khanapure, consultant functional neurosurgeon, Vikram Hospital, noted that Parkinson’s disease is an ageing-related disorder and has good treatment options, including tablets, injections, pump therapies, and surgeries. However no curative option is available yet, but gene-based therapy research and modification of underlying pathophysiology may see the light of the day in the near future.”
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